Download as PDF
Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations
rules can be found at 82 FR 44982
(September 27, 2017).
Regulatory Analysis of Amendments to
the Commission’s Rules
The Commission certifies that these
amendments to the Commission’s rules
will not have a significant economic
impact on a substantial number of small
entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) because it does
not create an economic impact and does
not affect small entities. The
amendments are concerned only with
the administration of Privacy Act
systems of records within the
Commission.
The amendments to the Commission’s
rules do not contain any information
collection requirements subject to the
provisions of the Paperwork Reduction
Act (44 U.S.C. 3501 et seq.).
No actions are necessary under title II
of the Unfunded Mandates Reform Act
of 1995, Public Law 104–4 (2 U.S.C.
1531–1538) because the amendments to
the Commission’s rules will not result
in the expenditure by State, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more in any one year (adjusted annually
for inflation), and will not significantly
or uniquely affect small governments.
The Commission has determined that
these rules do not meet the criteria
described in section 3(f) of Executive
Order 12866 (58 FR 51735, October 4,
1993) and thus do not constitute a
‘‘significant regulatory action’’ for
purposes of the Executive Order.
The amendments to the Commission’s
rules do not have Federalism
implications warranting the preparation
of a federalism summary impact
statement under Executive Order 13132
(64 FR 43255, August 10, 1999).
The amendments to the Commission’s
rules are not ‘‘major rules’’ as defined by
section 251 of the Small Business
Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.).
List of Subjects in 19 CFR Part 201
Administrative practice and
procedure.
For the reasons stated in the
preamble, under the authority of 19
U.S.C. 1335, the United States
International Trade Commission
amends 19 CFR part 201 as follows:
ethrower on DSK3G9T082PROD with RULES
2. In § 201.32, remove paragraphs (a)
and (b); redesignate paragraph (c) as
paragraph (a); revise the first sentence of
newly redesignated paragraph (a); and
add paragraph (b) to read as follows:
■
§ 201.32
Specific exemptions.
[FR Doc. 2017–27671 Filed 12–22–17; 8:45 am]
BILLING CODE 7020–02–P
1. The authority citation for part 201
continues to read as follows:
■
Authority: 19 U.S.C. 1335; 19 U.S.C. 2482,
unless otherwise noted.
VerDate Sep<11>2014
16:22 Dec 22, 2017
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. FDA–2017–N–6568]
(a) Pursuant to 5 U.S.C. 552a(k)(1), (5)
and (6), records contained in the system
entitled ‘‘Personnel Security
Investigative Files’’ have been exempted
from subsections (c)(3), (d), (e)(1),
(e)(4)(G) through (I) and (f) of the
Privacy Act. * * *
(b) Pursuant to 5 U.S.C. 552a(k)(1) and
(k)(2), records contained in the system
entitled ‘‘Freedom of Information Act
and Privacy Act Records’’ have been
exempted from subsections (c)(3), (d),
(e)(1), (e)(4)(G) through (I) and (f) of the
Privacy Act. Pursuant to section
552a(k)(1) of the Privacy Act, the
Commission exempts records that
contain properly classified information
pertaining to national defense or foreign
policy. Application of exemption (k)(1)
may be necessary to preclude
individuals’ access to or amendment of
such classified information under the
Privacy Act. Pursuant to section
552a(k)(2) of the Privacy Act, and in
order to protect the effectiveness of
Inspector General investigations by
preventing individuals who may be the
subject of an investigation from
obtaining access to the records and thus
obtaining the opportunity to conceal or
destroy evidence or to intimidate
witnesses, the Commission exempts
records insofar as they include
investigatory material compiled for law
enforcement purposes. However, if any
individual is denied any right, privilege,
or benefit to which he is otherwise
entitled under Federal law due to the
maintenance of this material, such
material shall be provided to such
individual except to the extent that the
disclosure of such material would reveal
the identity of a source who furnished
information to the Government under an
express promise that the identity of the
source would be held in confidence.
By order of the Commission.
Issued: December 19, 2017.
Lisa R. Barton,
Secretary to the Commission.
PART 201—RULES OF GENERAL
APPLICATION
60865
Medical Devices; Anesthesiology
Devices; Classification of the External
Negative Pressure Airway Aid
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the external negative
pressure airway aid into class II (special
controls). The special controls that
apply to the device type are identified
in this order and will be part of the
codified language for the external
negative pressure airway aid’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective December
26, 2017. The classification was
applicable on December 23, 2015.
FOR FURTHER INFORMATION CONTACT:
Todd Courtney, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2530, Silver Spring,
MD 20993–0002, 301–796–6371,
Todd.Courtney@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Upon request, FDA has classified the
external negative pressure airway aid as
class II (special controls), which we
have determined will provide a
reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation, in part by
reducing regulatory burdens by placing
the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
E:\FR\FM\26DER1.SGM
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60866
Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act and part 807 (21
U.S.C. 360(k) and 21 CFR part 807,
respectively).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 established the first procedure
for De Novo classification (Pub. L. 105–
115). Section 607 of the Food and Drug
Administration Safety and Innovation
Act modified the De Novo application
process by adding a second procedure
(Pub. L. 112–144). A device sponsor
may utilize either procedure for De
Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA shall classify the
device by written order within 120 days.
The classification will be according to
the criteria under section 513(a)(1) of
the FD&C Act. Although the device was
automatically placed within class III,
the De Novo classification is considered
to be the initial classification of the
device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application in order to market
a substantially equivalent device (see 21
U.S.C. 360c(i), defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On August 18, 2014, Sommetrics
submitted a request for De Novo
classification of the cNEP Airway
Management System. FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1) of the FD&C
Act.
We classify devices into class II if
general controls by themselves are
insufficient to provide reasonable
assurance of safety and effectiveness,
but there is sufficient information to
establish special controls that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
has determined that these special
controls, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of the device.
Therefore, on December 23, 2015,
FDA issued an order to the requester
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 868.5105. We
have named the generic type of device
external negative pressure airway aid,
and it is identified as a prescription
device that applies negative pressure to
a patient’s neck to aid in providing a
patent airway during procedures
requiring anesthesia.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
required to mitigate these risks in
table 1.
TABLE 1—EXTERNAL NEGATIVE PRESSURE AIRWAY AID RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
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Impaired blood flow ...................................................................................................................................
Failure of device or negative pressure mechanism ..................................................................................
Adverse tissue reaction .............................................................................................................................
Dislodging of plaque, leading to possible stroke .......................................................................................
Inadequate collar fit ...................................................................................................................................
Use error ....................................................................................................................................................
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. For a device
to fall within this classification, and
thus avoid automatic classification in
class III, it would have to comply with
the special controls named in this final
order. The necessary special controls
appear in the regulation codified by this
order. This device is subject to
VerDate Sep<11>2014
16:22 Dec 22, 2017
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premarket notification requirements
under section 510(k) of the FD&C Act.
At the time of classification, external
negative pressure airway aids are for
prescription use only. Prescription
devices are exempt from the
requirement for adequate directions for
use for the layperson under section
502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as
the conditions of 21 CFR 801.109 are
met.
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Clinical performance testing.
Non-clinical performance testing.
Biocompatibility.
Labeling.
Labeling.
Labeling.
III. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
E:\FR\FM\26DER1.SGM
26DER1
Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
the guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in part 814, subparts A
through E, regarding premarket
approval, have been approved under
OMB control number 0910–0231; the
collections of information in part 807,
subpart E, regarding premarket
notification submissions, have been
approved under OMB control number
0910–0120; and the collections of
information in 21 CFR part 801,
regarding labeling, have been approved
under OMB control number 0910–0485.
List of Subjects in 21 CFR Part 868
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 868 is
amended as follows:
PART 868—ANESTHESIOLOGY
DEVICES
1. The authority citation for part 868
is revised to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 868.5105 to subpart F to read
as follows:
■
ethrower on DSK3G9T082PROD with RULES
BILLING CODE 4164–01–P
(a) Identification. An external
negative pressure airway aid is a
prescription device that applies negative
pressure to a patient’s neck to aid in
providing a patent airway during
procedures requiring anesthesia.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Clinical performance testing must
document any adverse events observed
during clinical use, including impaired
blood flow, and demonstrate that the
device performs as intended under
anticipated conditions.
(2) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
patient positions, does not fail during
use, and does not lose negative pressure
16:22 Dec 22, 2017
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Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27784 Filed 12–22–17; 8:45 am]
§ 868.5105 External negative pressure
airway aid.
VerDate Sep<11>2014
capability. The following testing should
be performed:
(i) Ability of the device to maintain a
seal during various patient positions;
(ii) Device leakage testing to
demonstrate the device maintains
vacuum;
(iii) Drop testing to ensure the device
does not incur functional damage after
dropping the device; and
(iv) Functional testing after high and
low storage temperature.
(3) All patient contacting components
must be demonstrated to be
biocompatible.
(4) Labeling must include:
(i) A summary of clinical testing
results, including any adverse events
and evidence that effectiveness has been
achieved.
(ii) Technical specifications of the
device, including collar sizes, maximum
duration of use, operating temperature,
and storage temperature range.
(iii) Technical specifications of the
vacuum source, including maximum
vacuum level and operational vacuum
level.
(iv) Instructions for use that includes
how to place the device, determination
of size, verification of suction, reference
to training materials, and information
on troubleshooting the device if it does
not attach properly.
(v) A warning to screen patients for
carotid artery disease due to the
probable risk of the device to dislodge
arterial plaques in the carotid artery.
(vi) A warning to exclude patients
with anatomical abnormalities.
(vii) A warning not to use the device
during medical procedures involving
medications that contain propofol.
DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
Certifications and Exemptions Under
the International Regulations for
Preventing Collisions at Sea, 1972
Department of the Navy, DoD.
Final rule.
AGENCY:
ACTION:
The Department of the Navy
(DoN) is amending its certifications and
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972 (72 COLREGS), to reflect that
the Deputy Assistant Judge Advocate
SUMMARY:
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60867
General (DAJAG) (Admiralty and
Maritime Law) has determined that USS
TULSA (LCS 16) is a vessel of the Navy
which, due to its special construction
and purpose, cannot fully comply with
certain provisions of the 72 COLREGS
without interfering with its special
function as a naval ship. The intended
effect of this rule is to warn mariners in
waters where 72 COLREGS apply.
DATES: This rule is effective December
26, 2017 and is applicable beginning
December 7, 2017.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Kyle Fralick,
JAGC, U.S. Navy, Admiralty Attorney,
(Admiralty and Maritime Law), Office of
the Judge Advocate General, Department
of the Navy, 1322 Patterson Ave. SE,
Suite 3000, Washington Navy Yard, DC
20374–5066, telephone number: 202–
685–5040.
SUPPLEMENTARY INFORMATION: Pursuant
to the authority granted in 33 U.S.C.
1605, the DoN amends 32 CFR part 706.
This amendment provides notice that
the DAJAG (Admiralty and Maritime
Law), under authority delegated by the
Secretary of the Navy, has certified that
USS TULSA (LCS 16) is a vessel of the
Navy which, due to its special
construction and purpose, cannot fully
comply with the following specific
provisions of 72 COLREGS without
interfering with its special function as a
naval ship: Annex I paragraph 2 (a)(i),
pertaining to the height of the forward
masthead light above the hull; Annex I,
paragraph 2(f)(i), pertaining to the
placement of the masthead light or
lights above and clear of all other lights
and obstructions; Annex I, paragraph
2(f)(ii), pertaining to the vertical
placement of task lights; Annex I,
paragraph 3(a), pertaining to the
location of the forward masthead light
in the forward quarter of the ship, and
the horizontal distance between the
forward and after masthead light; Rule
27(b)(i) and Annex I, paragraph 9(b)(i),
pertaining to the arc of visibility of
middle tasks lights. The DAJAG
(Admiralty and Maritime Law) has also
certified that the lights involved are
located in closest possible compliance
with the applicable 72 COLREGS
requirements.
Moreover, it has been determined, in
accordance with 32 CFR parts 296 and
701, that publication of this amendment
for public comment prior to adoption is
impracticable, unnecessary, and
contrary to public interest since it is
based on technical findings that the
placement of lights on this vessel in a
manner differently from that prescribed
herein will adversely affect the vessel’s
ability to perform its military functions.
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26DER1

Agencies

[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Rules and Regulations]
[Pages 60865-60867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27784]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. FDA-2017-N-6568]
Medical Devices; Anesthesiology Devices; Classification of the
External Negative Pressure Airway Aid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the external negative pressure airway aid into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the external negative pressure airway aid's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.
DATES: This order is effective December 26, 2017. The classification
was applicable on December 23, 2015.
FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 20993-0002, 301-796-6371,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the external negative pressure
airway aid as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device
[[Page 60866]]
(see 21 U.S.C. 360c(f)(1)). We refer to these devices as
``postamendments devices'' because they were not in commercial
distribution prior to the date of enactment of the Medical Device
Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.
II. De Novo Classification
On August 18, 2014, Sommetrics submitted a request for De Novo
classification of the cNEP Airway Management System. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on December 23, 2015, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 868.5105. We have named
the generic type of device external negative pressure airway aid, and
it is identified as a prescription device that applies negative
pressure to a patient's neck to aid in providing a patent airway during
procedures requiring anesthesia.
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--External Negative Pressure Airway Aid Risks and Mitigation
Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Impaired blood flow........................ Clinical performance
testing.
Failure of device or negative pressure Non-clinical performance
mechanism. testing.
Adverse tissue reaction.................... Biocompatibility.
Dislodging of plaque, leading to possible Labeling.
stroke.
Inadequate collar fit...................... Labeling.
Use error.................................. Labeling.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
At the time of classification, external negative pressure airway
aids are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
[[Page 60867]]
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in part 814, subparts
A through E, regarding premarket approval, have been approved under OMB
control number 0910-0231; the collections of information in part 807,
subpart E, regarding premarket notification submissions, have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 868
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
868 is amended as follows:
PART 868--ANESTHESIOLOGY DEVICES
0
1. The authority citation for part 868 is revised to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 868.5105 to subpart F to read as follows:
Sec. 868.5105 External negative pressure airway aid.
(a) Identification. An external negative pressure airway aid is a
prescription device that applies negative pressure to a patient's neck
to aid in providing a patent airway during procedures requiring
anesthesia.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must document any adverse events
observed during clinical use, including impaired blood flow, and
demonstrate that the device performs as intended under anticipated
conditions.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated patient positions, does
not fail during use, and does not lose negative pressure capability.
The following testing should be performed:
(i) Ability of the device to maintain a seal during various patient
positions;
(ii) Device leakage testing to demonstrate the device maintains
vacuum;
(iii) Drop testing to ensure the device does not incur functional
damage after dropping the device; and
(iv) Functional testing after high and low storage temperature.
(3) All patient contacting components must be demonstrated to be
biocompatible.
(4) Labeling must include:
(i) A summary of clinical testing results, including any adverse
events and evidence that effectiveness has been achieved.
(ii) Technical specifications of the device, including collar
sizes, maximum duration of use, operating temperature, and storage
temperature range.
(iii) Technical specifications of the vacuum source, including
maximum vacuum level and operational vacuum level.
(iv) Instructions for use that includes how to place the device,
determination of size, verification of suction, reference to training
materials, and information on troubleshooting the device if it does not
attach properly.
(v) A warning to screen patients for carotid artery disease due to
the probable risk of the device to dislodge arterial plaques in the
carotid artery.
(vi) A warning to exclude patients with anatomical abnormalities.
(vii) A warning not to use the device during medical procedures
involving medications that contain propofol.
Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27784 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P